OCT 12, 2016
The FDA granted Genetech priority review based on a phase 3 study showing ranibizumab provided superior visual acuity gains compared with verteporfin photodynamic therapy (PDT), the only FDA-approved treatment for myopic choroidal neovascularization (mCNV).
The FDA grants Priority Review designation to medicines fort serious conditions that, if approved, would provide a significant improvement in safety or efficacy.
The phase 3 randomized, double-masked, multicenter study compared the efficacy and safety of Lucentis (0.5 mg) with PDT in 277 patients with visual impairment due to mCNV. Patients were randomized into 3 treatment groups: 106 patients received Lucentis on study day 1, at 1 month and as needed thereafter; 116 patients were treated with Lucentis on study day 1 and as needed thereafter; and 55 patients received PDT on study day 1 and then received treatment with Lucentis or PDT after month 3.
At 3 months, the Lucentis groups gained 10.5 and 10.6 letters compared with just 2.2 letters in the PDT group. The rate of ocular and non-ocular serious adverse events was low.